BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911393 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16040
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 30, 2012
    Report Date
    November 22, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WILL BE RETURNED AS THEY ARE EITHER STILL IMPLANTED OR SURGICALLY ABANDONED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOW SENSING MEASUREMENTS WERE NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD. THE CHANGE IN SENSING MEASUREMENTS OCCURRED AFTER A REVISION THAT OCCURRED SIX MONTHS PREVIOUSLY. IN ADDITION, THIS PACEMAKER HAD MIGRATED FROM THE PECTORAL POSITION TO A LATERAL LOCATION THAT WAS ALMOST IN THE PATIENT'S ARMPIT. ALL OTHER LEAD MEASUREMENTS WERE NORMAL AND POCKET MANIPULATION DID NOT CREATE ANY ABNORMAL MEASUREMENTS OR NOISE. A REVISION WAS PERFORMED AND IT WAS DISCOVERED THAT THE RV LEAD HAD DISLODGED AS A RESULT OF THE DEVICE MIGRATION. THE IS-1 PORTION WAS CAPPED AND A NEW PACE/SENSE LEAD WAS IMPLANTED. THE RV LEAD REMAINS IMPLANTED FOR DEFIBRILLATION PURPOSES ONLY. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AND SUCCESSFUL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND RV LEAD REMAIN IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18369 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0186

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R